Sagitta platform has originated 8 molecular assays (3 CE-IVD marked and 5 RUO), as well as a reagent, UlisseFaster (classified as RUO with pending CE-IVD). These assays and reagent are designed for the RT-PCR (Reverse Transcription – Polymerase Chain Reaction) technology.
The tests that obtained the CE-IVD marking and are ready to be marketed are the following:
- Ladymed / HPV Selfy for the detection of Human Papillomavirus (HPV), the agent responsible for cervical cancer, which allows the identification and genotyping of 14 variants of HPV in a single analysis;
- CoronaMelt, a diagnostic test for Sars- CoV-2 characterized by high sensitivity and high specificity thanks to the double analysis performed by means of the melting curves, thus reducing the risk of false negative and false positive results;
- CoronaMelt Var, a diagnostic assay for the detection and genotyping of Sars-CoV-2 variants (whose approval for CE-IVD marking has arrived in mid-June 2021).
- UlisseFaster is a reagent developed by UBM for the pre-treatment of biological samples that allows avoiding the phase related to the extraction and purification of DNA/RNA, such saving costs and reducing workflow and time required.
The other products (tests, reagent) currently classified as RUO include:
- Sexually Transmitted diseases: Chlamydia + Gonorrhea, Syphilis and other HPV types. At the moment, UBM has developed an assay for the concurrent detection of Chlamydia and Gonorrhea and one for identification of Syphilis. In addition, UBM has come up with two additional HPV diagnostic tests (“low-risk” HPV and “probably high- risk” HPV);
- HPV for Oropharyngeal cancer, a diagnostic test that allows the detection and genotyping of high-risk HPV present in paraffin-embedded samples of oropharyngeal cancer and in biopsies.
PEER-REVIEWED PUBLICATIONS
Pachetti M, Marini B, Benedetti F, Giudici F, Mauro E, Storici P, Masciovecchio C, Angeletti S, Ciccozzi M, Gallo RC, Zella D, Ippodrino R. Emerging SARS-CoV-2 mutation hot spots include a novel RNA-dependent-RNA polymerase variant. J Transl Med., 22, 179, (2020).
Benedetti F, Pachetti M, Marini B, Ippodrino R, Gallo RC, Ciccozzi M, Zella D. Inverse correlation between average monthly high temperatures and COVID-19-related death rates in different geographical areas. J Transl Med., 23, 251 (2020).
Pachetti M, Marini B, Giudici F, Benedetti F, Angeletti S, Ciccozzi M, Masciovecchio C, Ippodrino R, Zella D. Impact of lockdown on Covid-19 case fatality rate and viral mutations spread in 7 countries in Europe and North America. J Transl Med., 2, 338, (2020).
Benedetti F, Pachetti M, Marini B, Ippodrino R, Ciccozzi M, Zella D. SARS-CoV-2: March toward adaptation. J Med Virol., 92, 2274-2276, (2020).
Bonazza D, Avian A, Biagi B, Bussani R, Dal Cin E, Giudici F, Ippodrino R, Marini B, Mauro E, Rigo S, Santon D, Tirelli G, Tofanelli M, Zanconati F. Human PapillomaVirus genotyping in oropharyngeal squamous cell carcinoma without DNA extraction through EasyPap Direct HPV DNA test. Pathologica, 109, 337, (2017).
The NanoHybrid is a unique DNA/PNA (Peptide Nucleic Acid) based multi-modal biomolecule amplifying platform that can detect specific antibodies and protein analytes, rapidly and quantitatively, directly from serum or whole blood. These nano-explorers allow POC medical devices and self-testing tools to detect viruses and tumors with reduced time, reduced cost and with unparalleled accuracy.
The NanoHybrid platform was also developed for the application of personalized medicine. This platform has recently demonstrated clinically relevant therapeutic drug monitoring (TDM) (scrivilo in rosa o più grande), capabilities for a major oncology therapy, with a long list of other product prototypes in development. The NanoHybrid platform is also compatible with high- throughput automation applications, for the simultaneous analysis of hundreds of samples.
NanoHybrid leverages on a cutting edge technology with high potential and hence most of its pipeline is still under development. Management intends to target two applications in the therapeutic drug monitoring based on nano-switch:
- within the next 12 months UBM intends to start clinical validation of a full menu of tests (so far only one test has been developed, for Trastuzumab), which will be developed by steps / disease groups, with a target of at least 10 biomarkers to be used for drug monitoring purposes After validation these tests should become a revolutionary lab assays alternative to ELISA (Enzyme Linked Immuno-Sorbent Assay), today considered the gold standard in immunoassay.
- as a further evolution nano-switches will be used to create quantitative POC instruments for drug monitoring. However, this should take longer as the development will require a further step on the technology (electrochemical vs fluo cartridge reader) and this in turn will require a strategic partnership for the manufacturing of the hardware.
PEER-REVIEWED PUBLICATIONS
Mocenigo M, Porchetta A, Rossetti M, Brass E, Tonini L, Puzzi L, Tagliabue E, Triulzi T, Marini B, Ricci F, Ippodrino R. Rapid, Cost-Effective Peptide/Nucleic Acid-Based Platform for Therapeutic Antibody Monitoring in Clinical Samples. ACS Sens., 23, 3109-3115, (2020).
Rossetti M, Ippodrino R., Marini B, Palleschi G e Porchetta A. Antibody-Mediated Small Molecule Detection Using Programmable DNA-Switches. Anal Chem. 3, 8196-8201, (2018).
Ippodrino R. Programmable nucleic acid nanoswitches for the rapid, single-step detection of antibodies in bodily fluids. Journal of Acquired Immune Deficiency Syndrome, 77, (2018).
Porchetta A, Ippodrino B, Marini B, Caruso A, Ricci F. Programmable nucleic acid nano-switches for the rapid, single-step detection of antibodies in bodily fluids. J Am Chem Soc. 24, 947-953, (2018).
Our first application with the Sagitta platform is with Human Papilloma Virus (HPV) which is known to cause cervical and other cancers types. With HPV Selfy testing can be performed by self-sampling patients or clinicians using a simple swab to detect and diagnose HPV infection. Our technology has the unique ability to detect and genotype all 14 high-risk (hrHPV) variants without DNA extraction. This unprecedented technology reduces the complexity and cost of HPV testing and offers new pathways in diagnosis and treatment. With this new platform, we can screen for the presence of HPV and diagnose hrHPV on a scale never thought possible.
The HPV Selfy product is a unique approach allowing healthcare consumers to simple self-sample and give their clinicians the diagnostic power of genotyping hrHPV and the technology does not require DNA extraction allowing the lab to reduce complexity and cost resulting in a faster more efficient process.
HPV Selfy is targeting the 8 million HPV women globally are at risk of developing cervical cancer caused by Human Papillomavirus (HPV). The HPV testing market is expected to grow at a rate of 10% per year over the next 5 years.
HPV Selfy can screen for the presence of HPV and diagnose (high-risk) hrHPV at lower cost and greater scale than previously possible.
a. Source: QYR Pharma & Healthcare Research Center, Mar 2017
Cervical cancer is the fourth most frequent cancer in women with more than 500,000 cases worldwide and is mostly caused by a persistent infection of hrHPV genotypes. Just under $300 million is spent annually on HPV testing in the USA, with Europe as the next largest market at just under $200 million annually. Currently the CDC and World Health Organization recommend detecting cervical cell dysplasia through a Pap test with a co-test for HPV.
HPV is most closely associated with cervical cancer and categorized as a women’s health issue. In reality, HPV is a human issue in that men carry the virus and transmit the virus to their partners. Men are also susceptible to oral/pharyngeal and anogenital related cancers. There are no current commercial screening methods for men. Yet according to the CDC, all rates of HPV including; oral, anal/rectal and genital, are higher in men than in women.
HPV vaccines that prevent HPV 16 and 18 ( last vaccine prevent 7 out of 14 high risk HPV, old and first vaccine prevented only 16 and 18 genotypes = genotyping is important for controlling rare and new HPV genotypes diffusion) infections are now available and have the potential to reduce the incidence of cervical and other anogenital cancers. These vaccines are recommended for children under age 14, however, patient adoption has been lower then expected. The HPV vaccine will reduce the rates of infection in youths but not abate or reduce the need for screening in men and women who will continue to become infected with HPV and be carriers of the virus unless diagnosed. Although most variants and incidences of HPV clear themselves, to win the war on hrHPV variants and reduce HPV related cancers, routine screening and treatment must occur. This is a global public health issue.
Aptavir Among UBM’s platforms Aptavir is the one still at very early stage of development and consequently does not possess a detailed product pipeline yet. It has been created to develop and “produce” synthetic nucleic acid molecules, named aptamers, capable of limiting the infectivity of pathogens and that can be used for therapeutic or diagnostic purposes.
Aptamers are considered at the moment an undoubtedly high potential technology, as it should represent a) an effective and cheaper alternative to monoclonal antibodies in therapeutics; b) an innovative diagnostic tool; c) products with Simplify Regulatory Procedures, as no biologics are involved in production.
UBM applications will include:
- aptamers for therapeutic – inhibiting infection of viral pathogens (Sars-CoV-2); therapy and/or prevention of HPV infections, both genital and cutaneous.
- aptamers for additives and components of medical devices – skin creams, oils, lotion, topical creams, condom lubricants, genital gels for prevention or treatment of diseases.
